| CTRI Number |
CTRI/2025/09/094597 [Registered on: 11/09/2025] Trial Registered Prospectively |
| Last Modified On: |
10/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the Efficacy of Postbiotic Trybutyrin, probiotics, and Pre/Pro/Postbiotic fixed dose combination in Adults With Functional Gastrointestinal Disorders |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Controlled Clinical Trial To Evaluate The Safety And Efficacy Of Nutraceutical Formulations Containing Postbiotic Trybutyrin, Probiotics, And A Pre/Pro/Postbiotic Combination In Adults With Functional Gastrointestinal Disorders. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TRYBU-001-25, Version 1.0_Dated 28 April 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jothi Shankar |
| Designation |
Principal Investigator |
| Affiliation |
Srinivasan Rajalakshmi Memorial Hospital (SRMH) |
| Address |
Srinivasan Rajalakshmi Memorial Hospital (SRMH), Ground floor, Department of Gastroenterology, 11/77, 6th Cross Street, Voltas Colony, Nanganallur.
Chennai
TAMIL NADU
600061
India |
| Phone |
9941208262 |
| Fax |
|
| Email |
srmhresearch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jothi Shankar |
| Designation |
Principal Investigator |
| Affiliation |
Srinivasan Rajalakshmi Memorial Hospital (SRMH) |
| Address |
Srinivasan Rajalakshmi Memorial Hospital (SRMH), Ground floor, Department of Gastroenterology, 11/77, 6th Cross Street, Voltas Colony, Nanganallur.
Chennai
TAMIL NADU
600061
India |
| Phone |
9941208262 |
| Fax |
|
| Email |
srmhresearch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jothi Shankar |
| Designation |
Principal Investigator |
| Affiliation |
Srinivasan Rajalakshmi Memorial Hospital (SRMH) |
| Address |
Srinivasan Rajalakshmi Memorial Hospital (SRMH) Ground floor, Department of Gastroenterology, 11/77, 6th Cross Street, Voltas Colony, Nanganallur.
Chennai
TAMIL NADU
600061
India |
| Phone |
9941208262 |
| Fax |
|
| Email |
srmhresearch@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aeon Formulations Pvt Ltd |
|
|
Primary Sponsor
|
| Name |
Aeon Formulations Pvt Ltd |
| Address |
Plot No:21, Door No:2, Velu Naicker Street, Venkateshwara Nagar, Ramapuram, Chennai, Tamil Nadu 600089 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jothi Shankar |
Srinivasan Rajalakshmi Memorial Hospital |
Ground floor, Department of Gastroenterology,11/77, 6th Cross Street, Voltas Colony, Nanganallur,
Chennai-600061, Tamil Nadu, India.
Chennai
TAMIL NADU |
9884522606
srmhresearch@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Universal Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K219||Gastro-esophageal reflux disease without esophagitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
combination of prebiotics, probiotics, and postbiotic Trybutyrin. |
500mg capsule, oral once daily |
| Intervention |
Trybutyrin |
500mg capsule, oral once daily |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults aged 18 to 65 years.
2. Subjects with Rome IV criteria-based diagnosis of IBS, OR
Individuals with functional gastrointestinal symptoms (e.g., bloating, mild abdominal pain, altered bowel habits) but no serious underlying disease.
3. Stable clinical condition without acute illnesses.
4. Willing and able to provide written informed consent.
5. Capable of understanding and adhering to the protocol, including completion of the symptom diaries and follow-up visits. |
|
| ExclusionCriteria |
| Details |
1. Recent use of related interventions:
Use of antibiotics, probiotics, prebiotics, or postbiotics within 4 weeks prior to screening.
2. Gastrointestinal comorbidities:
History or presence of inflammatory bowel disease, celiac disease, gastrointestinal malignancies, GI surgeries (except appendectomy or hernia repair), or severe dysbiosis.
3. Chronic conditions:
Poorly controlled diabetes, renal, hepatic, or cardiovascular diseases.
4. Immunocompromised status:
Including HIV, cancer chemotherapy, or immunosuppressive therapy.
5. Pregnancy and lactation.
6. Known allergy or hypersensitivity to any component of the investigational products.
7. Participation in another clinical trial within the past 30 days.
8. Substance abuse or alcoholism history that may interfere with compliance or safety.
9. Psychiatric or cognitive disorders that may affect compliance or accurate symptom reporting. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of Postbiotic Trybutyrin, probiotics, and Pre/Pro/Postbiotic
FDC. |
Day 1, 15, 30, 45, and 59 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the safety and tolerability of all interventions.
To explore mechanisms of action |
Day 1, 15, 30, 45, and 59 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Introduction Postbiotics represent the next generation of gut microbiota-targeted therapies beyond probiotics and prebiotics. Trybutyrin (tributyrin) delivers bioavailable butyrate, a short-chain fatty acid essential for gut integrity, metabolic balance, and immune modulation. |